Coronavirus live updates: Europe’s regulator to decide on Pfizer vaccine by Dec. 29

first_imgMyriam Borzee/iStockBy MORGAN WINSOR, ERIN SCHUMAKER and IVAN PEREIRA, ABC News(NEW YORK) — A pandemic of the novel coronavirus has now infected more than 63.3 million people and killed over 1.4 million worldwide, according to real-time data compiled by the Center for Systems Science and Engineering at Johns Hopkins University.Here’s how the news is developing Tuesday. All times Eastern:Dec 01, 8:57 amNetherlands makes face masks mandatory indoorsPeople are now required to wear face masks in all indoor public spaces in the Netherlands.The Dutch government is one of the last in Europe to introduce such a mandate.The new rule, which came into force Tuesday, applies to everyone over the age of 13 when in publicly accessible, covered places such as airports, barber shops and hair salons, covered car parks and gas stations, public transportation including platforms, town halls and retail stores. Students and teachers will also have to wear masks when walking around school buildings but not when seated during lessons.Places of worship and buildings not accessible to the general public are exempt.Those who ignore the mask mandate face a fine of up to 95 euros (about $114).Dec 01, 7:47 amEx-CDC head says this is ‘the single most complicated vaccination program in American history’The former director of the U.S. Centers for Disease Control and Prevention said that although he expects a COVID-19 vaccine to be approved soon, he also anticipates “some bumps in the road.”“When you vaccine millions of people, some people get really sick after the vaccination and you don’t know whether that was the vaccine or that was just coincidence. So that has to be studied carefully or you’re going to get all sorts of wild rumors flying around,” Dr. Tom Frieden, who is now the president and CEO of Resolve to Save Lives, told ABC News chief anchor George Stephanopoulos in an interview Tuesday on Good Morning America.“There may be production problems, there may be rumors, there may be people who don’t want to take it even if you do have the vaccine,” he added. “So this is probably, George, the single most complicated vaccination program in American history.”Although a vaccine may be right around the corner, Frieden said people must remain vigilant this winter by wearing masks, washing hands, practicing social distancing and avoiding indoor gatherings.“We have to double down on safety protocols or we’re going to see the worst season we’ve yet had for COVID,” he warned. “We can all do more.”Dec 01, 7:26 amEurope’s regulator to decide on Pfizer/BioNTech vaccine by Dec. 29, Moderna’s by Jan. 12The European Medicines Agency (EMA) said Tuesday that it could decide by Dec. 29 whether to recommend granting a conditional marketing authorization for a COVID-19 vaccine developed by U.S. pharmaceutical giant Pfizer and its German partner BioNTech.Meanwhile, the European drug regulator said its assessment of another COVID-19 vaccine developed by American biotechnology company Moderna, which has also applied for a conditional marketing authorization, could be completed by Jan. 12.In the European Union, conditional marketing authorizations allow for the approval of medicines or vaccines “that fulfill an unmet medical need on the basis of less complete data than normally required,” according to the EMA. However, the data must show that the benefits outweigh any risks, and companies must provide further data from ongoing or new studies once a conditional marketing authorization has been granted.The EMA said its reviews of both vaccine candidates “will proceed under an accelerated timeline” and that decisions could be issued “within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine.”“Such a short timeframe is only possible because EMA has already reviewed some data on the vaccine during a rolling review,” the agency said in a statement Tuesday. “These timelines are based on the type of data assessed so far in the context of the rolling review and may be subject to change as evaluation proceeds.”If the EMA decides to recommend granting a conditional marketing authorization, the agency said the European Commission will then fast-track its decision-making process with a view to granting an authorization that’s valid in all EU and European Economic Area member states “within days.”Dec 01, 5:56 amPfizer, BioNTech seek vaccine approval in EuropeU.S. pharmaceutical giant Pfizer and its German partner BioNTech said they have submitted an application for conditional approval of their COVID-19 vaccine with the European Medicines Agency.The submission, which occurred Monday, completes the rolling review process that the two companies initiated with the regulator on Oct. 6.“Today’s announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need,” Pfizer chairman and CEO Albert Bourla said in a statement Tuesday. “We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us.”If the vaccine candidate, called BNT162b2, is approved, the companies said it could potentially be available for use in Europe before the end of the year.“As a company located in the heart of Europe, today’s milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2,” BioNTech CEO and co-founder Ugur Sahin said in a statement Tuesday. “We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life.”Dec 01, 5:27 amUS reports over 157,000 new casesThere were 157,901 new cases of COVID-19 confirmed in the United States on Monday, according to a real-time count kept by Johns Hopkins University.It’s the 28th straight day that the country has reported over 100,000 newly diagnosed infections. Monday’s count is down from a peak of 205,557 new cases last Friday.An additional 1,172 fatalities from COVID-19 were also registered nationwide on Monday, less than the all-time high of 2,609 new deaths on April 15.COVID-19 data may be skewed in the coming days and weeks due to possible lags in reporting over Thanksgiving followed by a potentially very large backlog from the holiday.A total of 13,545,017 people in the United States have been diagnosed with COVID-19 since the pandemic began, and at least 268,087 of them have died, according to Johns Hopkins. The cases include people from all 50 U.S. states, Washington, D.C. and other U.S. territories as well as repatriated citizens.Much of the country was under lockdown by the end of March as the first wave of pandemic hit. By May 20, all U.S. states had begun lifting stay-at-home orders and other restrictions put in place to curb the spread of the novel coronavirus. The day-to-day increase in the country’s cases then hovered around 20,000 for a couple of weeks before shooting back up over the summer.The numbers lingered around 40,000 to 50,000 from mid-August through early October before surging again to record levels, crossing 100,000 for the first time on Nov. 4 and reaching 200,000 for the first time on Nov. 27.Copyright © 2020, ABC Audio. All rights reserved.last_img read more

South Korea COVID-19 infections ‘in full swing’ after protest outbreak

first_imgKwon urged all demonstrators to get tested immediately at nearby public health clinics to protect the vulnerable around them.The demonstration may have been a “catalyst” for the nationwide outbreak, as churchgoers chartered buses to the capital from their homes across the country, including the southern port of Busan, Kwon said.Nods not hugs South Korea has reported 16,346 cases of the new coronavirus with 307 COVID-19 deaths.If infections continue rising at the current rate or accelerate, authorities say they will likely impose the strictest level of social distancing – closing schools, requiring employees to work from home and limiting gatherings to 10 people.”Please do not make physical contact. Exchange nods instead of handshakes,” Kwon said. “Refrain from physical contact such as hugging.”At least 53 of the new infections are linked to the Sarang Jeil Church, bringing the group’s total to 676. Hundreds more church members are being traced for testing.Infections from the Seoul rally and one on Aug. 8 include people from nine cities and provinces. Health authorities said epidemiological work is underway in 150 facilities, including the workplaces of infected church members.Sixty infections, including 33 from the church, have been linked to the anti-government rallies in Seoul, which drew thousands of people. At least 8,500 demonstrators had been tested as of Thursday, Kwon said.The government has banned in-person church meetings in the greater Seoul area – an urban sprawl of 25 million people – and closed other high-risk locations, including nightclubs, karaoke bars, buffets and cyber cafes.The Seoul city government restricted rallies there to fewer than 10 people from Friday through the rest of August.Topics : South Korea’s coronavirus infections are back “in full swing” and spreading nationwide after members of a church attended a political demonstration, authorities said on Thursday, threatening one of the world’s COVID-19 success stories.The Korea Centers for Disease Control and Prevention (KCDC) reported 288 new cases as of midnight on Wednesday, marking a week of triple-digit daily increases, although down slightly from the previous day’s 297.”This is a grave situation that could possibly lead to a nationwide pandemic,” Vice Health Minister Kim Gang-lip told a briefing. Without aggressive contact tracing, the country could experience the types of spikes and continued infections witnessed in the United States and Europe, said KCDC deputy director Kwon Jun-wook.”Consider the COVID-19 pandemic now to be in full-swing.”South Korea was one of the first countries outside China to see an explosive spread of the new coronavirus, but intensive tracing and testing had brought infections under control and quelled a subsequent series of spikes.The latest outbreak is driven by hundreds of infections among members of a church run by a far-right preacher. They had attended an anti-government protest in Seoul on Aug. 15, the 75th anniversary of the Japan’s World War Two surrender and the end of colonial rule.last_img read more

Thai protest brought forward over disruption fears

first_imgSo far pro-royalist demonstrations have been small, compared to the tens of thousands who joined the biggest anti-government demonstration in September.”We are here to fight for democracy,” said Romtum Cheyhert, 63, who joined the anti-government protest from the northern city of Chiang Mai.Among protesters’ demands are for curbs on the constitutional powers of the king and for him to transfer back the personal control he took of some army units and a palace fortune valued in the tens of billions of dollars.Royalist politician Warong Dechgitvigrom condemned the protesters in a Facebook post on Wednesday and called on the government to prosecute those he accused of intending to destroy the monarchy. Thai anti-government protesters hurriedly brought forward a demonstration in Bangkok on Wednesday, saying they feared confrontation with royalist groups planning to assemble nearby in support of the king.Three months of protests demanding a new constitution and the departure of Prime Minister Prayuth Chan-ocha – a former junta leader – have largely been peaceful, although demonstrators scuffled with police on Tuesday and 21 activists were arrested.Protesters have also sought to curb the powers of King Maha Vajiralongkorn and in a rare direct challenge, chanted “release our friends” at his passing motorcade on Tuesday. A couple of hundred protesters began assembling from 8 a.m. (0100 GMT) at Bangkok’s Democracy Monument on the anniversary of a 1973 uprising that brought down the then military government. The protest had originally been scheduled for six hours later.”We are having the protest earlier because they are getting supporters to receive the royal motorcade to start a conflict with us,” protest leader and human rights lawyer Arnon Nampa told protesters. “We are holding this protest peacefully.”The government made no immediate comment, but has said people have the right to protest. The Palace has repeatedly declined to comment on the protests or the demands of protesters.Pro-royalist groups said they planned gatherings near the anti-government protest, raising fears of trouble in a country roiled by a decade of street violence between supporters and opponents of the establishment before a 2014 coup.center_img Topics :last_img read more